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GLP-1 Receptor Agonist

Semaglutide for Opioid Use Disorder

Phase 2
Waitlist Available
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Initiated sublingual buprenorphine (SL-BUP) treatment within 60 days of enrollment
Be older than 18 years old
Must not have
Current or lifetime diagnosis of Type 1 or Type 2 diabetes
Use of any GLP-1 agonist medications in the prior 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline

Summary

This trial is testing the effects of semaglutide on people with opioid use disorder who are starting buprenorphine treatment. Participants will receive either semaglutide injections or a placebo for

Who is the study for?
This trial is for individuals starting treatment with buprenorphine for opioid use disorder. Participants will be randomly assigned to receive either semaglutide or a placebo in weekly injections over 12 weeks.
What is being tested?
The study tests if semaglutide affects cravings and reactions to drug cues in people with opioid addiction. It's also looking at how safe and tolerable the drug is as a potential treatment option.
What are the potential side effects?
Possible side effects of semaglutide may include digestive issues like nausea, vomiting, diarrhea, constipation, and abdominal pain; risk of low blood sugar; headache; fatigue; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I started taking buprenorphine under the tongue within the last 60 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with diabetes.
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I haven't taken any GLP-1 agonist medications in the last 3 months.
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I plan to take GLP-1 agonist medications during the trial.
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My liver function tests are more than three times the normal limit, or I have severe kidney problems.
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I or my family have a history of thyroid cancer or MEN2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weekly for 12 weeks, and at follow-up visit (within 2 weeks of week 12).
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weekly for 12 weeks, and at follow-up visit (within 2 weeks of week 12). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cue-induced Cravings for Opioids
Relapse to Illicit Opioid Use
Secondary study objectives
Assessment of blind
Blood pressure
Blood sugar
+15 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
This arm will receive semaglutide (n=23). All participants will initially receive 0.25mg for 4 weeks, and then as tolerated dose will be increased to 0.5mg for 4 weeks. Then as tolerated, the dose will be increased to 1.0mg for 4 weeks.
Group II: PlaceboPlacebo Group1 Intervention
This arm will receive saline placebo (n=23).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,658 Previous Clinical Trials
11,699,526 Total Patients Enrolled
~31 spots leftby Feb 2027
Unbiased ResultsWe believe in providing patients with all the options.
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